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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 066 Date of Entry 05/25/2026 
FR Recognition Number 16-240
Standard
ISO  7176-21 Third edition 2025-04
Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
Scope/Abstract
This document specifies requirements and test methods for electromagnetic emissions and for electromagnetic immunity of electrically powered wheelchairs and scooters, intended for indoor or outdoor use, or both, by people with disabilities. It is also applicable to manual wheelchairs with an add-on power kit. It is not applicable to vehicles designed to carry more than one person.

This document also specifies requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters.

A reference configuration is specified for adjustable wheelchairs and scooters in order to enable test results to be used for comparison of performance.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 7176-21 Second edition 2009-04-01 [Rec# 16-166] will be superseded by recognition of ISO 7176-21 Third edition 2025-04 [Rec# 16-240]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-166] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 16-166] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
Relevant FDA Guidance and/or Supportive Publications*
1. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition Number: 19-36).
2. ANSI RESNA WC-2:2019 Section 21; American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters (Recognition Number: 16-224).


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ambarish Pawar
  CDRH/OPEQ/OHTV/DHTVB
  --
  ambarish.pawar@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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